Among other accolades, Shire is a proficient drug development and manufacturing outsourcing organization. So why is the recent excitement from Shire about a large facility “build,” instead of an external services “buy”? Matt Walker, EVP of Technical Operations, explains for Outsourced Pharma readers why Shire built its state-of-the-art plasma manufacturing facility just east of Atlanta, Georgia.
In pharmaceutical outsourcing, RFP templates are a time-saving and efficient tool to initiate and control a bidding process. Using them properly allows a sponsor to collect comparable proposals that create leverage for negotiation. (If you're not using one, why not?)
In 2004, the FDA published an aspirational guidance for industry on process analytical technology. This article describes examples where industry has succeeded in meeting the FDA guidance.
This, the second installment in a series, covers factors in installing a liposome manufacturing process in a facility and the engineering points to consider in doing so.
When developing a parenteral product, pharmaceutical scientists are faced with a variety of choices – choices that can be conflicting or present differing advantages. With careful planning and strategic foresight, these advantages can be leveraged to great effect during the development program. Read the whitepaper to learn more.
Biopharmaceutical executives must consider how outsourcing fits into their development and production strategy, as well as how to select the best CDMO partner for their business. Here’s a step-by-step guide to help make that decision.
When asked about the biggest challenges to the pharmaceutical company sponsor-contract service provider relationship, sponsors and service providers offer pretty consistent responses.
The use of monoclonal antibodies (MAbs) and MAb conjugates as biopharmaceuticals have increased over the last decade. As a result, more cost-effective, efficient, and flexible process purification solutions are of high priority for MAb manufacturers. Increasing product titers upstream can introduce challenges in downstream purification processes. With increased MAb titers, the cell culture supernatant might contain an elevated number of impurities (e.g., aggregates) that need to be separated from the target molecule.
Dedicated Fermentation Technology Replacing Stainless Steel Systems in Bioprocess Markets
How starting early, building options into your process, understanding the lead times, and continuing to evaluate your strategy can reduce uncertainty in your plans.
Through the implementation of automation, data management, and analytical technologies, pharma has the opportunity to breathe new life into a number of areas of the biologics drug development process.
Troubleshooting problems and attempting to identify and prevent potential problems is a typical activity for most businesses.
Bio-developers are adopting more sophisticated processes, such as perfusion, to address low titer cell lines and reduce raw material costs. They’re also seeking more flexible R&D and PD capabilities.
Biosimilars are considered to be one of the fastest growing sectors of the pharmaceutical industry.
Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.
About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.
About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.
Through the implementation of automation, data management, and analytical technologies, pharma has the opportunity to breathe new life into a number of areas of the biologics drug development process.
In a scenario where manufacturing processes move to a continuous flow, analyzers are producing data simultaneously, necessitating real-time processing and cloud-based tools for data management.
A problem with traditional mAb manufacturing is that there are so many potential entry points for microbial contamination. There are, however, ways to shut the door on contamination.
The $330 bn global sterile market is expected to reach $525 bn by 2020, growing at a CAGR of 11% -with North America contributing 48% while APAC is expected to record highest CAGR of 13%.
Small and emerging companies face significant challenges in today’s market. This calls for an alternative solution to help them achieve success. One option is a single-source solution, which can eliminate the silos that can often exist in today’s outsourcing paradigm, increasing both communication and speed.
